RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>40032-794-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-794-05) </PackageDescription>
    <NDC11Code>40032-0794-05</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-794-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (40032-794-01) </PackageDescription>
    <NDC11Code>40032-0794-01</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-794-02</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (40032-794-02) </PackageDescription>
    <NDC11Code>40032-0794-02</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-794-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (40032-794-10) </PackageDescription>
    <NDC11Code>40032-0794-10</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-794-50</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (40032-794-50) </PackageDescription>
    <NDC11Code>40032-0794-50</NDC11Code>
    <ProductNDC>40032-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>43386-794-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (43386-794-05) </PackageDescription>
    <NDC11Code>43386-0794-05</NDC11Code>
    <ProductNDC>43386-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207558</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment:. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis ., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci ., 5 Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis ., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis ., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum ., 9 Relapsing fever due to Borrelia recurrentis .</IndicationAndUsage>
    <Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. With a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients are: colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, ethyl alcohol and a coating containing hypromellose, polyethylene glycol, titanium dioxide, FD&amp;C Blue No. 2 and FD&amp;C Yellow No. 6.</Description>
  </NDC>
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    <NDCCode>51991-794-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (51991-794-05) </PackageDescription>
    <NDC11Code>51991-0794-05</NDC11Code>
    <ProductNDC>51991-794</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
    <NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120613</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091689</ApplicationNumber>
    <LabelerName>Breckenridge Pharmaceutical, Inc</LabelerName>
    <SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120613</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52904-794-05</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (52904-794-05)  &gt; 2 TABLET, COATED in 1 POUCH</PackageDescription>
    <NDC11Code>52904-0794-05</NDC11Code>
    <ProductNDC>52904-794</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advil</ProprietaryName>
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    <DosageFormName>TABLET, COATED</DosageFormName>
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    <StartMarketingDate>19840518</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018989</ApplicationNumber>
    <LabelerName>Wyeth Pharmaceuticals Company</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-794-05</NDCCode>
    <PackageDescription>57 g in 1 TUBE (59088-794-05) </PackageDescription>
    <NDC11Code>59088-0794-05</NDC11Code>
    <ProductNDC>59088-794</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diabecin Cs Cream</ProprietaryName>
    <NonProprietaryName>Menthol, Capsaicin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250610</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Puretek Corporation</LabelerName>
    <SubstanceName>CAPSAICIN; MENTHOL</SubstanceName>
    <StrengthNumber>.0005; .02</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>74588-794-05</NDCCode>
    <PackageDescription>18927 mL in 1 DRUM (74588-794-05) </PackageDescription>
    <NDC11Code>74588-0794-05</NDC11Code>
    <ProductNDC>74588-794</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hygienex Lavender Field Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Global Impact Innovation LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>72</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>40032-022-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-022-05) </PackageDescription>
    <NDC11Code>40032-0022-05</NDC11Code>
    <ProductNDC>40032-022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Linezolid</ProprietaryName>
    <NonProprietaryName>Linezolid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160822</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207526</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>LINEZOLID</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.1); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.2); Uncomplicated skin and skin structure infections (1.2); Vancomycin-resistant Enterococcus faecium infections (1.3). To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.4).</IndicationAndUsage>
    <Description>Linezolid Tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4- morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below:. Linezolid tablets for oral administration contain 600 mg linezolid, supplied as white, oval, film-coated tablets, debossed with "n 022" on one side and plain on other side. Inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidine, magnesium stearate, titanium dioxide, polydextrose, hypromellose, triacetin, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-034-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (40032-034-05) </PackageDescription>
    <NDC11Code>40032-0034-05</NDC11Code>
    <ProductNDC>40032-034</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Moxifloxacin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207285</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Moxifloxacin hydrochloride is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below. Community Acquired Pneumonia (1.1). Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3). Complicated Intra-Abdominal Infections (1.4). Plague (1.5). Acute Bacterial Sinusitis (1.6). Acute Bacterial Exacerbation of Chronic Bronchitis (1.7). To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride and other antibacterial drugs. Moxifloxacin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.8).</IndicationAndUsage>
    <Description>Moxifloxacin hydrochloride is a synthetic antibacterial agent for oral and intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8  diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals with a molecular weight of 437.9. Its empirical formula is C21H24FN3O4*HCl and its chemical structure is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-088-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (40032-088-05) </PackageDescription>
    <NDC11Code>40032-0088-05</NDC11Code>
    <ProductNDC>40032-088</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207371</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-089-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (40032-089-05) </PackageDescription>
    <NDC11Code>40032-0089-05</NDC11Code>
    <ProductNDC>40032-089</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160524</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207371</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-351-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-351-05) </PackageDescription>
    <NDC11Code>40032-0351-05</NDC11Code>
    <ProductNDC>40032-351</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206142</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
    <StrengthNumber>300; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-352-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-352-05) </PackageDescription>
    <NDC11Code>40032-0352-05</NDC11Code>
    <ProductNDC>40032-352</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206142</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
    <StrengthNumber>300; 7.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-353-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-353-05) </PackageDescription>
    <NDC11Code>40032-0353-05</NDC11Code>
    <ProductNDC>40032-353</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206142</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
    <StrengthNumber>300; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-356-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-356-05) </PackageDescription>
    <NDC11Code>40032-0356-05</NDC11Code>
    <ProductNDC>40032-356</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206245</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
    <StrengthNumber>325; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-357-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-357-05) </PackageDescription>
    <NDC11Code>40032-0357-05</NDC11Code>
    <ProductNDC>40032-357</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206245</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
    <StrengthNumber>325; 7.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-358-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-358-05) </PackageDescription>
    <NDC11Code>40032-0358-05</NDC11Code>
    <ProductNDC>40032-358</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206245</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
    <StrengthNumber>325; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-430-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-430-05) </PackageDescription>
    <NDC11Code>40032-0430-05</NDC11Code>
    <ProductNDC>40032-430</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204021</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   (1). Limitations of Use (1). Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride    USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-431-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-431-05) </PackageDescription>
    <NDC11Code>40032-0431-05</NDC11Code>
    <ProductNDC>40032-431</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204021</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   (1). Limitations of Use (1). Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride    USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-432-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-432-05) </PackageDescription>
    <NDC11Code>40032-0432-05</NDC11Code>
    <ProductNDC>40032-432</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204021</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   (1). Limitations of Use (1). Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride    USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-433-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-433-05) </PackageDescription>
    <NDC11Code>40032-0433-05</NDC11Code>
    <ProductNDC>40032-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204021</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   (1). Limitations of Use (1). Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride    USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-434-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (40032-434-05) </PackageDescription>
    <NDC11Code>40032-0434-05</NDC11Code>
    <ProductNDC>40032-434</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204021</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   (1). Limitations of Use (1). Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride    USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-540-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-540-05) </PackageDescription>
    <NDC11Code>40032-0540-05</NDC11Code>
    <ProductNDC>40032-540</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203602</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1), 2 Morphine sulfate extended-release tablets is not indicated as an as-needed (prn) analgesic. (1).</IndicationAndUsage>
    <Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &amp;C Blue #2 /Indigo carmine aluminum lake and FD&amp;C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&amp;C Red # 27/Phloxine aluminum lake and FD&amp;C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD &amp; C Blue # 2/ Indigo carmine aluminum lake, FD &amp; C yellow # 6 /Sunset yellow. FCF aluminum lake and FD &amp; C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-541-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-541-05) </PackageDescription>
    <NDC11Code>40032-0541-05</NDC11Code>
    <ProductNDC>40032-541</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203602</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1), 2 Morphine sulfate extended-release tablets is not indicated as an as-needed (prn) analgesic. (1).</IndicationAndUsage>
    <Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &amp;C Blue #2 /Indigo carmine aluminum lake and FD&amp;C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&amp;C Red # 27/Phloxine aluminum lake and FD&amp;C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD &amp; C Blue # 2/ Indigo carmine aluminum lake, FD &amp; C yellow # 6 /Sunset yellow. FCF aluminum lake and FD &amp; C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
  </NDC>
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    <NDCCode>40032-542-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-542-05) </PackageDescription>
    <NDC11Code>40032-0542-05</NDC11Code>
    <ProductNDC>40032-542</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203602</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1), 2 Morphine sulfate extended-release tablets is not indicated as an as-needed (prn) analgesic. (1).</IndicationAndUsage>
    <Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &amp;C Blue #2 /Indigo carmine aluminum lake and FD&amp;C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&amp;C Red # 27/Phloxine aluminum lake and FD&amp;C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD &amp; C Blue # 2/ Indigo carmine aluminum lake, FD &amp; C yellow # 6 /Sunset yellow. FCF aluminum lake and FD &amp; C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-543-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-543-05) </PackageDescription>
    <NDC11Code>40032-0543-05</NDC11Code>
    <ProductNDC>40032-543</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203602</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1), 2 Morphine sulfate extended-release tablets is not indicated as an as-needed (prn) analgesic. (1).</IndicationAndUsage>
    <Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &amp;C Blue #2 /Indigo carmine aluminum lake and FD&amp;C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&amp;C Red # 27/Phloxine aluminum lake and FD&amp;C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD &amp; C Blue # 2/ Indigo carmine aluminum lake, FD &amp; C yellow # 6 /Sunset yellow. FCF aluminum lake and FD &amp; C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>40032-544-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-544-05) </PackageDescription>
    <NDC11Code>40032-0544-05</NDC11Code>
    <ProductNDC>40032-544</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203602</ApplicationNumber>
    <LabelerName>Novel Laboratories, Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1). Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1), 2 Morphine sulfate extended-release tablets is not indicated as an as-needed (prn) analgesic. (1).</IndicationAndUsage>
    <Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD &amp;C Blue #2 /Indigo carmine aluminum lake and FD&amp;C Blue #1/Brilliant blue FCF aluminum lake. The 30 mg tablets also contain: D&amp;C Red # 27/Phloxine aluminum lake and FD&amp;C Blue #.1/Brilliant blue FCF aluminum lake. The 60 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Yellow #6 / Sunset yellow FCF aluminum Lake. The 100 mg tablets also contain: FD &amp; C Blue # 2/ Indigo carmine aluminum lake, FD &amp; C yellow # 6 /Sunset yellow. FCF aluminum lake and FD &amp; C red # 40/Allura red aluminum lake. The 200 mg tablets also contain: D&amp;C Yellow #10 aluminum lake and FD&amp;C Blue #1/ Brilliant blue FCF aluminum. lake. Morphine sulfate is an white to off-white crystalline powder. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
  </NDC>
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